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The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.

IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses.

IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technique to aid the clinician in identifying the nerve bundles in the ear.

This document is a 510(k) clearance letter for the NeurAxis IB-Stim device. It does not contain the detailed acceptance criteria or the study protocol and results that would prove the device meets specific performance metrics typically associated with AI/ML-driven medical devices. Instead, it focuses on substantial equivalence to a predicate device and provides a brief summary of a clinical study supporting an expanded indication for use.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set with provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, training set details) are not present in this document.

However, I can extract information related to the device, its intended use, and the summarized clinical evidence presented for the expanded indication.

Here's what can be extracted from the provided text, addressing the questions where possible and noting when information is unavailable:

Device: NeurAxis IB-Stim
Classification: Class II
Regulation: 21 CFR 876.5340 - Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
Product Code: QHH
Predicate Device: NeurAxis, Inc. IB-Stim (K241533)
Indication for Use (Expanded): The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS and FD. FD patients for whom IB-Stim is indicated have also been shown to experience reduction of nausea symptoms.
Reason for new 510(k): Expansion of the indication to include functional dyspepsia (FD).

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically applied to AI/ML software (e.g., in terms of metrics like sensitivity, specificity, AUC) is not directly applicable to this 510(k) summary. This device is a hardware stimulator. The "performance" assessment here is about clinical effectiveness for a new indication, not an algorithmic output.

The information primarily addresses clinical efficacy for the expanded indication of Functional Dyspepsia (FD).

Study Details (for Expanded FD Indication)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 23 subjects who met Rome III criteria for FD. This was a subgroup analysis.
   • Data Provenance: Extracted from a prospective study that enrolled 115 adolescents with pain-associated DGBIs. The origin of the broader study (e.g., country) is not specified in this document. The study design was prospective, but the analysis for this specific submission was a post-hoc analysis of a subgroup.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable in the context of this device. The "ground truth" here is the patient's self-reported pain and nausea, assessed relative to a baseline, within a clinical trial setting. There's no image interpretation or diagnostic performance that would require expert consensus for ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This study is a clinical efficacy trial comparing a device to a sham, with patient-reported outcomes. Adjudication methods like 2+1 are typically for diagnostic assessments (e.g., image reading).
   • The study involved a sham control arm, which serves as a method to control for placebo effect and natural history of the condition.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI/ML diagnostic device that assists human readers. It is a therapeutic nerve stimulator.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Outcomes Data: Patient-reported abdominal pain reduction (at least 30%) and qualitative reduction in nausea symptoms. Patients met Rome III criteria for FD at enrollment.

7. The sample size for the training set:

   • Not applicable. This device is hardware; it does not involve AI/ML training on a dataset. The term "training set" would not apply in this context. The study described is a clinical efficacy validation for an expanded indication.

8. How the ground truth for the training set was established:

   • Not applicable (as above).

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RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.

RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 60 adults
• Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
• For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.

8. The sample size for the training set:

The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established:

As there is no machine learning model or training set, this question is not applicable.

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The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.

IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses.

IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technician in identifying the nerve bundles in the ear.

The provided FDA 510(k) document for the NeurAxis IB-Stim (01-1020) does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NeurAxis, Inc. IB-Stim – DEN180057) to justify its market clearance.

The document explicitly states: "There are no changes to the device design. Therefore, previously conducted testing in DEN180057 remains applicable and no additional performance testing is required." This indicates that the 510(k) relies on the performance data and acceptance criteria established for the predicate device.

However, the document does mention updates to the "intended treatment population" and "treatment duration" with clinical literature supporting these changes. This implies that while no new performance testing was required for the device itself, the justification for these expanded indications likely involved a review of existing clinical evidence.

Given the information provided, it's not possible to populate all the requested sections. Here's what can be inferred or stated as not provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document for K241533 does not describe a new test set or its provenance for device performance. It refers to "clinical literature" for supporting expanded indications. This literature would represent a collection of studies, each with its own sample size and provenance, but these details are not aggregated or provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no new test set is described for K241533. For the predicate device, or within the supporting clinical literature, this information would have been specific to each study, but it is not provided in this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new test set is described for K241533.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The NeurAxis IB-Stim is a nerve stimulator, not an AI-assisted diagnostic device. Therefore, MRMC studies related to human reader improvement with AI are not relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The NeurAxis IB-Stim is a medical device, not a standalone software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the expanded indications (age range, treatment duration), the document states that "Real world evidence including clinical literature support these changes" and "Recommendation from the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) based on clinical literature and current practice of medicine support the 4-week treatment. In addition, clinical literature supports safe and effective use of the IB-Stim device in children as young as 8 years old." This implies that the 'ground truth' for validating the expanded indications relies on clinical outcomes data and expert consensus/recommendations derived from existing clinical literature.

8. The sample size for the training set

Not applicable, as this device is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as this device is not an AI/machine learning device that requires a training set.

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